Label: I.C. IVY BLOCK- zinc acetate lotion
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NDC Code(s):
59555-200-01,
59555-200-03,
59555-200-04,
59555-200-07, view more59555-200-08, 59555-200-10, 59555-200-11, 59555-200-16
- Packager: R & R Lotion, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 24, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other Information
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Inactive Ingredients
Di Water, Cyclopentasiloxane (and) Quaternium - 90 Bentonite (and) Trifluoromethyl C1-4 Alkyl Dimethicone (and) Propylene Carbonate, Bentonite, Dimethicone, Polyacrylamide (and) c13-14 Isoparaffin (and) Laureth-7, Glycerin, Magnesium Aluminum Silicate, Phenoxyethanol (and) Ethylhexlglycerin, PVP, Aloe Barbadensis Leaf Juice, Disodium EDTA, Hamamelis Virginiana (Witch Hazel) Water (and) Phenoxyethanol, Citric Acid
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- PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label
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INGREDIENTS AND APPEARANCE
I.C. IVY BLOCK
zinc acetate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) QUATERNIUM-90 (UNII: BE5VYX4VP8) BENTONITE (UNII: A3N5ZCN45C) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE CARBONATE (UNII: 8D08K3S51E) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-200-03 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/21/2021 2 NDC:59555-200-04 59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/21/2021 3 NDC:59555-200-07 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/21/2021 4 NDC:59555-200-08 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/21/2021 5 NDC:59555-200-10 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/21/2021 6 NDC:59555-200-11 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/21/2021 7 NDC:59555-200-01 5 mL in 1 PACKET; Type 0: Not a Combination Product 09/21/2021 8 NDC:59555-200-16 4 mL in 1 PACKET; Type 0: Not a Combination Product 09/21/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/21/2021 Labeler - R & R Lotion, Inc (062979000)